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目的 研究尼莫地平在健康人体的药动学和相对生物利用度。方法 8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和被测制剂 12 0mg ,采用HPLC法测定用药后不同时间的血药浓度。结果两种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (190 4 1± 2 6 5 0 ) μg·h·L-1和 (186 2 4± 2 7 80 ) μg·h·L-1,Cmax分别为 (5 7 15± 7 4 1) μg·L-1和 (5 4 94± 10 0 0 ) μg·L-1,Tmax分别为 (0 97± 0 14 )h和 (1 0 1± 0 18)h。被测制剂的相对生物利用度为 (98 0 1± 9 5 1) %。结论 用NDST软件对两种制剂的AUC、Cmax、Tmax等进行双向单侧t检验 ,表明两种制剂具有生物等效性
Objective To study the pharmacokinetics and relative bioavailability of nimodipine in healthy volunteers. Methods Eight healthy volunteers were randomized to receive nimodipine standard reference drug and 120 mg of test drug in a single-dose randomized crossover study. Plasma concentrations were determined by HPLC at different time points. Results The in vivo process of the two preparations were in accordance with the one-compartment open model with AUC of (190 4 1 ± 26 650) μg · h · L-1 and (186 ± 4 ± 2780) μg · h · L -1 and Cmax were (57 ± 14) 1 μg · L-1 and (544 ± 10 0 0) μg · L-1, respectively, and the Tmax were (0 97 ± 0 14) h and 0 1 ± 0 18) h. The relative bioavailability of the tested formulations was (98 0 1 ± 9 5 1)%. Conclusion Two-way one-sided t-test of AUC, Cmax, Tmax, etc. of two preparations by NDST software showed that the two preparations have bioequivalence